VIVACE Electrosurgical System
K-Number: K150409 · 2016-01-15
ApplicantSung Hwan E&B Co.,Ltd
Decision Date2016-01-15
Product CodeOUH
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
VIVACE Electrosurgical System is a medical device manufactured by Sung Hwan E&B Co.,Ltd. It received FDA 510(k) clearance on 2016-01-15 under approval number K150409. The device is classified under product code OUH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VIVACE Electrosurgical System?
VIVACE Electrosurgical System is a medical device that received FDA 510(k) clearance on 2016-01-15. It is manufactured by Sung Hwan E&B Co.,Ltd. The 510(k) number is K150409.
When was VIVACE Electrosurgical System approved by the FDA?
VIVACE Electrosurgical System received FDA 510(k) clearance on 2016-01-15, under approval number K150409.
What company makes VIVACE Electrosurgical System?
VIVACE Electrosurgical System is manufactured by Sung Hwan E&B Co.,Ltd.
What is the FDA product code for VIVACE Electrosurgical System?
The FDA product code for VIVACE Electrosurgical System is OUH.
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Official Source
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